FDA.reportPublic FDA data

Insertion Tool Short 2.5

Primary DI
07290112280909
Brand
Insertion Tool Short 2.5
Company
DENTACK IMPLANTS LTD
Model
ITS-250
Device description
Insertion Tool Short 2.5
Published
2019-03-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290112280909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290112280909072901122809097290112280909

GMDN Terms#

Term, Definition table
TermDefinition
Dental torque wrenchA hand-held dental tool intended for the manual application of rotation to tighten/loosen/remove a device [e.g., dental implant, spatial register (localizer/tracker/calibrator)] fitted into or close to the oral cavity, and/or to a surgical instrument, in association with a dental surgical procedure [e.g., dental guided surgery registration]. It may have a built-in ratchet function, with forward and reverse direction, and a calibrated scale to which a recommended torque can be set; it is not a screwdriver. It is typically made of metallic or polymer materials and may have a standard socket connection to accommodate different tool bits/adaptors. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+97297660379info@pyramidion-is.com

Regulatory Flags#

DUNS number
514897185
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290112280824ET-1250ET-12502019-03-02
07290112280831Expansion tool-screw 6.35+wrench short - AssyET-18502019-03-02
07290112280848Expansion tool EX-screw 6.35+wrench long-AssyET-1250EX2019-03-02
07290112280855Expansion tool EX-screw+wrench short - AssyET-1850EX2019-03-02
07290112280862Long Driver 1.25DL-1252019-03-02
07290112280879Short Driver 1.25DS-1252019-03-02
07290112280886Hand Driver for Cover ScrewHD092019-03-02
07290112280893Insertion Tool Long 2.5ITL-2502019-03-02
07290112280916"Torque Ratchet Hex 1/4"" Wheel"RT-35002019-03-02
07290112280541Impression copingsIC-7502018-02-23
07290112280664Implant 4.1*5EDI-41052019-02-27
07290112280671Straight MU AbutmentMU-412N2019-02-27
07290112280688Multi Unit Abutment for EXMU-412EXN2019-02-26
07290112280695Straight MU AbutmentMU-413N2019-02-27
07290112280701Multi Unit Abutment for EXMU-413EXN2019-02-26
07290112280718Straight MU AbutmentMU-414N2019-02-27
07290112280725Multi Unit Abutment for EXMU-414EXN2019-02-26
07290112280732Angled MU abutment MU-17152019-02-27
07290112280749Angled MU abutment 17-1.5 for EXMU-1715EX2019-02-26
07290112280756Angled MU abutment MU-17302019-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800313235715SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235722SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235739SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235746SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235753SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235760SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235777SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235784SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235791SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235807SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235814SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235821SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235838SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235845SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235852SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235869SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235876SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235883SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235890SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235906SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235913SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235920SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235937SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235944SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235951SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235968SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235975SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235982SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235999SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313236002SQ Guide Long DrillDENTIS CO. ,LTDNDP2026-07-09